한국임상약학회지 (Korean Journal of Clinical Pharmacy)

  • 제29권4호
  • /
  • Pages.267-277
  • /
  • 2019
  • /
  • 1226-6051(pISSN)
  • /
  • 2508-786X(eISSN)
한국임상약학회 (Korean College Of Clinical Pharmacy)
권호 표지
DOI QR코드

DOI QR Code

한국의 다지역 임상시험 가이드라인 적용에 대한 인식: 다중 이해관계자 설문조사

Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey

  • 손민지 (서울대학교 약학대학, 종합약학연구소) ;
  • 송윤경 (서울대학교 약학대학, 종합약학연구소) ;
  • 전아영 (서울대학교 약학대학, 종합약학연구소) ;
  • 오정미 (서울대학교 약학대학, 종합약학연구소) ;
  • 김인화 (서울대학교 약학대학, 종합약학연구소)
  • Sohn, Minji (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University) ;
  • Song, Yun-Kyoung (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University) ;
  • Jeon, Ah Young (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University) ;
  • Oh, Jung Mi (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University) ;
  • Kim, In-Wha (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University)
  • 투고 : 2019.09.07
  • 심사 : 2019.12.09
  • 발행 : 2019.12.31
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Backgrounds: With the globalization of drug development, multi-regional clinical trials (MRCTs) have emerged to facilitate rapid availability of medicines to patients worldwide. The present study aimed to has explored attitudes and perceptions towards adopting the Korean MRCT guideline. Methods: An online survey, consisting of 16 questions, classified into two subjects, was administered to stakeholders in Korea. Most quantitative components were measured using the Likert scales. A content analysis of the qualitative components was carried out to identify the keywords in open-ended responses. Results: A total of 94 survey responses were analyzed: 51 participants from pharmaceutical companies, 11 from clinical research organizations, and 21 from clinical trial centers. The content of the guideline was rated as appropriate for clarity, acceptability, and applicability (96.8, 96.8, and 93.6%, respectively). The local environmental impact of the systemic/political, academic/technical, and industrial/economical aspects of the guideline was rated as appropriate at 95.7, 97.9, and 91.5%, respectively. The suggested adoption period was 1~2 years (40, 42.6%). The concept and individuals' domestic circumstances were the key problems affecting the clarity, applicability, and local environmental impact of the guideline. Conclusion: The Korean MRCT guideline was well-developed. Their overall impact on the local environmental impact of MRCTs in Korea was expected to be beneficial, but methods are needed to minimize the negative impacts. The findings of this study can inform the priorities for the future adoption of the guideline in Korea.

키워드

참고문헌

  1. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. E17 General principles for planning and design of Multi-Regional Clinical Trials Draft. ICH 2016. Available from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E17/E17EWG_Step2_2016.pdf. Accessed August 26, 2016.
  2. Weisfeld V and Lustig TA. International Regulatory Harmonization Amid Globalization of Drug Development. In: Workshop Summary of Forum on Drug Discovery, Development, and Translation; Board on Health Sciences Policy; Institute of Medicine (IOM), Washington, Oct 24, 2013:5-9.
  3. Quan H, Mao X, Tanaka Y, et al. Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials. Contemp Clin Trials 2017;58:13-22. https://doi.org/10.1016/j.cct.2017.04.009
  4. Shenoy P. Multi-regional clinical trials and global drug development. Perspect Clin Res 2016;7:62-7. https://doi.org/10.4103/2229-3485.179430
  5. Vickers A, Goyal N, Harland R, et al. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials 1998;19:159-66. https://doi.org/10.1016/S0197-2456(97)00150-5
  6. Okie S. Multinational medicines-ensuring drug quality in an era of global manufacturing. N Engl J Med 2009;361:737-40. https://doi.org/10.1056/NEJMp0903870
  7. Davis JR, Nolan VP, Woodcock J, et al. Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. In: Workshop Report of Institute of Medicine (US) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Washington, April 14-15, 1998.
  8. Song Y, Sohn M, Jeon AY, et al. Regulations and guidelines for planning and design of multi-regional clinical trials. Korean J Clin Pharm 2018;28:146-53. https://doi.org/10.24304/kjcp.2018.28.2.146
  9. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Basic principles on global clinical trials. PMDA 2007. Available from https://www.pmda.go.jp/files/000153265.pdf. Accessed December 4, 2019.
  10. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Basic Principles on Global Clinical Trials (Reference Cases). PMDA 2012. Available from https://www.pmda.go.jp/files/000157520.pdf. Accessed December 4, 2019.
  11. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Basic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global Clinical Trials. PMDA 2014. Available from https://www.pmda.go.jp/files/000157777.pdf. Accessed December 4, 2019.
  12. National Medical Products Administration. International multicenter clinical trials Guidelines (Trial) Draft. CFDA 2014. Available from http://samr.cfda.gov.cn/WS01/CL0001/. Accessed August 26, 2016.
  13. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. E17 General principles for planning and design of Multi-Regional Clinical Trials. ICH 2017. Available from https://database.ich.org/sites/default/files/E17EWG_Step4_2017_1116.pdf. Accessed December 4, 2019.
  14. Gastroenterology and Metabolism Products Division, Drug Evaluation Department. General principles for planning and design of Multi-Regional Clinical Trials. National Institue of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety 2018. Available from http://www.nifds.go.kr/brd/m_15/view.do?seq=12555&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1. Accessed December 4, 2019.
  15. Dillman DA, Smyth JD, Christian LM. Internet, Mail and Mixed-Mode Surveys: The Tailored Design Method, 3rd Edition. Hoboken: Wiley, 2009:94-168, 301-50.
  16. Reagans R. Survey Sample Size Calculator. Available from http://fluidsurveys.com/university/survey-sample-size-calculator/. Accessed August 26, 2016.
  17. Brouwers MC, Kho ME, Browman GP, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ 2010;182:E839-42. https://doi.org/10.1503/cmaj.090449
  18. Fervers B, Burgers JS, Voellinger R, et al. Guideline adaptation: an approach to enhance efficiency in guideline development and improve utilisation. BMJ Qual Saf 2011;20:228-36. https://doi.org/10.1136/bmjqs.2010.043257
  19. Hsieh HF and Shannon SE. Three approaches to qualitative content analysis. Qual Health Res 2005;15:1277-88. https://doi.org/10.1177/1049732305276687
  20. Elo S and Kyngas H. The qualitative content analysis process. J Adv Nurs 2008;62:107-15. https://doi.org/10.1111/j.1365-2648.2007.04569.x
  21. Tavakol M and Dennick R. Making sense of Cronbach's alpha. Int J Med Educ 2011;2:53-5. https://doi.org/10.5116/ijme.4dfb.8dfd
  22. Binkowitz B and Ibia E. Multiregional Clinical Trials: An Introduction From an Industry Perspective. Drug Inf J 2011;45:569-73. https://doi.org/10.1177/009286151104500606
  23. Singh J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. J Pharmacol Pharmacother 2015;6:185-7. https://doi.org/10.4103/0976-500X.162004
  24. Siering U, Eikermann M, Hausner E, et al. Appraisal tools for clinical practice guidelines: a systematic review. PLoS One 2013;8:e82915. https://doi.org/10.1371/journal.pone.0082915
  25. MacDermid JC, Brooks D, Solway S, et al. Reliability and validity of the AGREE instrument used by physical therapists in assessment of clinical practice guidelines. BMC Health Serv Res 2005;5:18. https://doi.org/10.1186/1472-6963-5-18
  26. Hoffmann-Esser W, Siering U, Neugebauer EAM, et al. Guideline Appraisal With AGREE II: Systematic Review of the Current Evidence on How Users Handle the 2 Overall Assessments. PLoS One 2017;12:e0174831. https://doi.org/10.1371/journal.pone.0174831
  27. Zhang X, Zhao K, Bai Z, et al. Clinical Practice Guidelines for Hypertension: Evaluation of Quality Using the AGREE II Instrument. Am J Cardiovasc Drugs 2016;16:439-51. https://doi.org/10.1007/s40256-016-0183-2
  28. Yang C, Zhang Z, Zhang L, et al. Quality assessment of clinical practice guidelines on tic disorders with AGREE II instrument. Psychiatry Res 2018;259:385-91. https://doi.org/10.1016/j.psychres.2017.08.060
  29. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. E5(R1) Ethnic Factors in the Acceptabilify of Foreign Clinical Data. ICH 1998. Available from https://database.ich.org/sites/default/files/E5_R1__Guideline.pdf. Accessed December 4, 2019.
  30. Yi S, An H, Lee H, et al. Korean, Japanese, and Chinese populations featured similar genes encoding drug-metabolizing enzymes and transporters: a DMET Plus microarray assessment. Pharmacogenet Genomics 2014;24:477-85. https://doi.org/10.1097/fpc.0000000000000075
  31. Hasunuma T, Tohkin M, Kaniwa N, et al. Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians. Br J Clin Pharmacol 2016;81:1078-90. https://doi.org/10.1111/bcp.12884
  32. Gehring M, Taylor RS, Mellody, et al. Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study). BMJ Open 2013;3:e002957. https://doi.org/10.1136/bmjopen-2013-002957
  33. Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ 2009;180:277-8. https://doi.org/10.1503/cmaj.082041
  34. Korean National Enterprise for Clinical Trials. The right place for clinical tirals in Asia. KoNECT 2017. Available from https://www.konect.or.kr/upload/downfile/Start_with_Korea_2017.pdf. Accessed December 4, 2019.
  35. Rajadhyaksha V. Conducting feasibilities in clinical trials: an investment to ensure a good study. Perspect Clin Res 2010;1:106-9. https://doi.org/10.4103/2229-3485.71767
  36. Chen J, Quan H, Gallo P, et al. An adaptive strategy for assessing regional consistency in multiregional clinical trials. Clin Trials 2012;9:330-9. https://doi.org/10.1177/1740774512440635
  37. Tsou HH, Tsong Y, Chang WJ, et al. Design and analysis issues of multiregional clinical trials with different regional primary endpoints. J Biopharm Stat 2012;22:1051-9. https://doi.org/10.1080/10543406.2012.701586
  38. Chen YH and Wang M. Assessing dose-region profile of drug efficacy: a multiregional trial strategy. J Biopharm Stat 2012;22:894-902. https://doi.org/10.1080/10543406.2012.701577
  39. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000;32:1008-15. https://doi.org/10.1046/j.1365-2648.2000.t01-1-01567.x
  40. Wong LP. Focus group discussion: a tool for health and medical research. Singapore Med J 2008;49:256-60.